MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 CORAIL2 STD SIZE 9; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L92509
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient underwent primary total hip re-pavement on (b)(6) 2009 where an asr resurfacing cup with a corail stem was utilized.Patient has presented with a clunking hip in deep flexion and some pain as well as metallosis.On opening the hip, blackened tissue was evident anterior to the cup.There was some soft tissue impingement with metallosis.This black tissue was removed (pseudo tumor) and the asr 300 shell removed.The asr xl head and sleeve were removed from the stem.Corrosion was evident at the head neck junction.The stem was left in situ and a biomet dual mobility shell implanted with a new 28mm metal head.Doi: (b)(6) 2009, dor: (b)(6) 2021, unknown hip.
Additional Manufacturer Narrative
Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicated that there was no surgical delay and the affected side involved in this event was the right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.Reviewing the photos provided on the attachments the reported events cannot be confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: CORAIL2 STD SIZE 9
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12882522
• Report Number: 1818910-2021-26370
• Device Sequence Number: 20034375
• Product Code: LPH
• UDI-Device Identifier: 10603295168751
• UDI-Public: 10603295168751
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3L92509
• Device Catalogue Number: 3L92509
• Device Lot Number: 2811696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 02/11/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 12/27/2021; 02/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASR 300 SPIKED CUP SIZE 50; CORAIL2 STD SIZE 9; DEPUY ASR XL FEM IMP SIZE 45; LARGE MOD HEAD ADAPT 12/14 +5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female